ABSTRACT
Characterization of hazard (qualitative) and assessment of risk (quantitative) potentially associated with human exposure to a new substance are important elements of drug development. There is a regulatory and ethical requirement that evidence of acceptable risk must be obtained in non-human systems before first administration of a drug candidate to volunteers or patients. Further non-clinical safety data are generated thereafter in phase with clinical trials, and to support post-marketing use. Provision of such safety information from in vivo and in vitro studies is the responsibility of a department known as Non-(or Pre)- clinical Safety Assessment, Toxicology’, or a related term. However, it should be recognized that the administration of pharmacologically active materials to humans will always carry some element of risk, which must be weighed carefully against the severity of the targeted indication, the nature of the patient population and the availability of other effective therapies. That is, a rigorous and favourable risk-benefit assessment must be demonstrated before a new product can successfully be brought to the market.
